MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS BOWED STEM PLANER; INSTRUMENT, KNEE

Model Number	BP-1417M-03N
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component involved met specification.The instrument was returned for further analysis and this report will be supplemented when further information is made available.
Event or Problem Description
A bowed planer used during a surgery was not properly preparing the bone.The surgeon had to ream up the intramedullary canal and the bowed planer worked better.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component involved met specification.Additionally, the instrument was returned, and a visual and dimensional analysis was performed, and it was identified that the instrument was within specification.The instrument initially not functioning as intended could not be attributed to the manufacturing of the component or a nonconformance.Should additional information be obtained the report will be supplemented.
Event or Problem Description
A bowed planer used during a surgery was not properly preparing the bone.The surgeon had to ream up the intramedullary canal and the bowed planer worked better.

• Brand Name: ELEOS BOWED STEM PLANER
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 9109770
• Report Number: 3013450937-2019-00062
• Device Sequence Number: 19278085
• Product Code: KRO
• UDI-Device Identifier: B278BP1417M03N0
• UDI-Public: B278BP1417M03N0
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BP-1417M-03N
• Device Catalogue Number: BP-1417M-03N
• Device Lot Number: SC25836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR